Schizophrenia Clinical Trial
Official title:
Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
Schizophrenia represents a significant contributor to the global burden of disease, with this burden disproportionately impacting low- and middle-income countries (LMICs). In India, the burden due to schizophrenia is further exacerbated by low access to effective psychosocial interventions aimed at promoting recovery, rehabilitation, and community tenure, as well as inadequate attention to managing co-occurring chronic medical conditions that result in significantly reduced life expectancy among those living with schizophrenia compared to the general population. A major driver of these alarming gaps in access to care for persons with schizophrenia in India is the limited capacity within primary care settings aimed at addressing the complex co-occurring mental health, physical health, and functional needs of this patient population. There now exists strong evidence demonstrating that community programs delivered in primary care and leveraging psychosocial interventions combined with linkage to specialty psychiatric services are effective for supporting treatment and recovery of schizophrenia in low-resource settings. We will leverage our existing collaboration and robust research infrastructure in both rural and urban settings in Madhya Pradesh and Karnataka, India to conduct a hybrid type 1 effectiveness-implementation trial to evaluate whether the use of a digital platform offers added clinical benefit and can support integration of this task shared care for schizophrenia into routine primary care settings. We will address the following aims: 1) evaluate whether the use of the mindLAMP digital platform can enhance the clinical effectiveness of task-shared community-based psychosocial rehabilitation (COPSI) for individuals with schizophrenia, and 2) determine whether the addition of mindLAMP to the delivery of the COPSI program has an impact on implementation metrics when compared to delivery of COPSI alone.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | December 2028 |
Est. primary completion date | July 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Primary diagnosis of schizophrenia per IDC-10 diagnostic criteria for research and an illness duration of greater than 12 months and overall moderate level of severity on the CGI-SCH scale - At least one risk factor for early mortality (e.g. hypertension, diabetes, dyslipidemia, etc) - Willingness to stay in the study area during the trial period - Ability to operate a smartphone Exclusion Criteria: - Major visual impairment or inability to operate a smartphone - Cognitive impairment or diagnosis of dementia - Planning to move out of the study area in the next 12 months - Does not speak Hindi or Kannada |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Harvard Medical School (HMS and HSDM) | All India Institute of Medical Sciences, Bhopal, Beth Israel Deaconess Medical Center, National Institute of Mental Health and Neuro Sciences, India, Sangath |
Bondre AP, Shrivastava R, Raghuram H, Tugnawat D, Khan A, Gupta S, Kumar M, Mehta UM, Keshavan M, Lakhtakia T, Chand PK, Thirthalli J, Patel V, Torous J, Rozatkar AR, Naslund JA, Bhan A. A qualitative exploration of perceived needs and barriers of individuals with schizophrenia, caregivers and clinicians in using mental health applications in Madhya Pradesh, India. SSM Ment Health. 2022 Dec;2:100063. doi: 10.1016/j.ssmmh.2022.100063. — View Citation
Cohen A, Naslund JA, Chang S, Nagendra S, Bhan A, Rozatkar A, Thirthalli J, Bondre A, Tugnawat D, Reddy PV, Dutt S, Choudhary S, Chand PK, Patel V, Keshavan M, Joshi D, Mehta UM, Torous J. Relapse prediction in schizophrenia with smartphone digital phenotyping during COVID-19: a prospective, three-site, two-country, longitudinal study. Schizophrenia (Heidelb). 2023 Jan 27;9(1):6. doi: 10.1038/s41537-023-00332-5. — View Citation
Lakhtakia T, Bondre A, Chand PK, Chaturvedi N, Choudhary S, Currey D, Dutt S, Khan A, Kumar M, Gupta S, Nagendra S, Reddy PV, Rozatkar A, Scheuer L, Sen Y, Shrivastava R, Singh R, Thirthalli J, Tugnawat DK, Bhan A, Naslund JA, Patel V, Keshavan M, Mehta UM, Torous J. Smartphone digital phenotyping, surveys, and cognitive assessments for global mental health: Initial data and clinical correlations from an international first episode psychosis study. Digit Health. 2022 Nov 8;8:20552076221133758. doi: 10.1177/20552076221133758. eCollection 2022 Jan-Dec. — View Citation
Naslund JA, Tyagi V, Khan A, Siddiqui S, Kakra Abhilashi M, Dhurve P, Mehta UM, Rozatkar A, Bhatia U, Vartak A, Torous J, Tugnawat D, Bhan A. Schizophrenia Assessment, Referral and Awareness Training for Health Auxiliaries (SARATHA): Protocol for a Mixed-Methods Pilot Study in Rural India. Int J Environ Res Public Health. 2022 Nov 13;19(22):14936. doi: 10.3390/ijerph192214936. — View Citation
Rodriguez-Villa E, Mehta UM, Naslund J, Tugnawat D, Gupta S, Thirthalli J, Bhan A, Patel V, Chand PK, Rozatkar A, Keshavan M, Torous J. Smartphone Health Assessment for Relapse Prevention (SHARP): a digital solution toward global mental health - CORRIGENDUM. BJPsych Open. 2021 Feb 5;7(2):e48. doi: 10.1192/bjo.2021.6. No abstract available. — View Citation
Rodriguez-Villa E, Rozatkar AR, Kumar M, Patel V, Bondre A, Naik SS, Dutt S, Mehta UM, Nagendra S, Tugnawat D, Shrivastava R, Raghuram H, Khan A, Naslund JA, Gupta S, Bhan A, Thirthall J, Chand PK, Lakhtakia T, Keshavan M, Torous J. Cross cultural and global uses of a digital mental health app: results of focus groups with clinicians, patients and family members in India and the United States. Glob Ment Health (Camb). 2021 Aug 24;8:e30. doi: 10.1017/gmh.2021.28. eCollection 2021. — View Citation
Tyagi V, Khan A, Siddiqui S, Kakra Abhilashi M, Dhurve P, Tugnawat D, Bhan A, Naslund JA. Development of a Digital Program for Training Community Health Workers in the Detection and Referral of Schizophrenia in Rural India. Psychiatr Q. 2023 Jun;94(2):141-163. doi: 10.1007/s11126-023-10019-w. Epub 2023 Mar 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pittsburgh Sleep Questionnaire Index (PSQI) | 19-item self-report measure of sleep quality for patients with psychiatric disorders | Baseline, 6 months, and 12 months | |
Other | EuroQol-5D (EQ5D) | 25-item self-report standardized measure of health status and quality of life to provide a generic measure of health for clinical appraisal | Baseline, 6 months, and 12 months | |
Other | Social Functioning Scale (SFS) | A measure with 7 subscales used to assess functioning in patients with psychosis | Baseline, 6 months, and 12 months | |
Other | Framingham Risk Score | A measure used to assess cardiovascular risk using quantitative information to aid in targeting lower risk factors | Baseline, 6 months, and 12 months | |
Primary | Indian Disability Evaluation and Assessment Scale (IDEAS) | - 4-domain self-report measure detecting the level of disability in psychiatric patients in India which generates a global score of severity of disability (0-20) with increasing scores indicating more severe disabilities | Baseline, 6 months, and 12 months | |
Secondary | Positive and Negative Syndrome Scale (PANSS) | 30-item self-report measure of positive and negative symptoms and general psychopathology | Baseline, 6 months, and 12 months | |
Secondary | Generalized Anxiety Disorder Assessment-7 (GAD-7) | 7-item self-report measure of anxiety symptom severity based on DSM-5 criteria | Baseline, 6 months, and 12 months | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | 9-item self-report measure of depression severity based on DSM-5 criteria | Baseline, 6 months, and 12 months | |
Secondary | Clinical Global Impression-Schizophrenia (CGI-SCH) Scale | 7-item self-report measure of severity of schizophrenia, each component of the CGI-SCH is waited separately and does not yield a global score | Baseline, 6 months, and 12 months | |
Secondary | Brief Assessment of Cognition in Schizophrenia (BACS) | Newly developed instrument to assess aspects of cognition in patients with schizophrenia | Baseline, 6 months, and 12 months |
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